Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2026-01-02 @ 12:40 AM
Study NCT ID:
NCT02719132
Status:
WITHDRAWN
Last Update Posted:
2016-05-20
First Post:
2016-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of DapagliFLOzin on Quality of Life in Patients With Type 2 Diabetes in a Real Clinical PrActice
Sponsor:
AstraZeneca
Organization:
Study Overview
Official Title:
A Multicentre Randomised Open-Label Crossover 2-Period 2 Treatment Clinical Trial to Evaluate Effect of Dapagliflozin 10 mg Once Daily on the Quality of Life in Patients With Type 2 Diabetes
Status:
WITHDRAWN
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FLORA
Brief Summary:
This is a multicenter, randomised, open-label, crossover, 2-period comparative phase IV study.
The primary objective is to compare the effect of dapagliflozin 10 mg once daily in combination with metformin at a daily dose of ≤1,500 mg vs. metformin monotherapy with dose titrated up to 2,500 mg/day on the overall quality of life, obesity-specific quality of life and treatment satisfaction in patients with type 2 diabetes.
The primary objective is to compare the effect of dapagliflozin 10 mg once daily in combination with metformin at a daily dose of ≤1,500 mg vs. metformin monotherapy with dose titrated up to 2,500 mg/day on the overall quality of life, obesity-specific quality of life and treatment satisfaction in patients with type 2 diabetes.
Detailed Description:
The study will comprise the following phases: Screening, Treatment Period 1 and Treatment Period 2.
After screening examinations and assessments, all patients enrolled will be randomly assigned in equal proportion (1:1) to either study arm:
Arm 1:
* Patients will take dapagliflozin 10 mg in combination with metformin ≤ 1,500 mg (daily dose) for 24 weeks during Treatment Period 1
* Patients will be on metformin monotherapy with dose titrated up to 2,500 mg/day for further 24 weeks during Treatment Period 2
Arm 2 (the same treatment phases in reverse order):
* Patients will be on metformin monotherapy with dose titrated up to 2,500 mg/day for 24 weeks during Treatment Period 1
* Patients will take dapagliflozin 10 mg in combination with metformin ≤ 1,500 mg (daily dose) for further 24 weeks during Treatment Period 2 Following the randomisation procedure, patients will receive investigational products at each visit as scheduled by Treatment Period 1. After the Randomisation Visit (Visit 2), the patient should attend the study centre for Visits 3, 4, and 5 (Day 28, Day 86, and Day 168, respectively) for efficacy and safety assessments. At Visit 5 (Day 168), the patient will receive investigational products as required by Treatment Period 2. Further Visits 6, 7 and 8 will be scheduled on Day 196, Day 252, Day 336, respectively.
After screening examinations and assessments, all patients enrolled will be randomly assigned in equal proportion (1:1) to either study arm:
Arm 1:
* Patients will take dapagliflozin 10 mg in combination with metformin ≤ 1,500 mg (daily dose) for 24 weeks during Treatment Period 1
* Patients will be on metformin monotherapy with dose titrated up to 2,500 mg/day for further 24 weeks during Treatment Period 2
Arm 2 (the same treatment phases in reverse order):
* Patients will be on metformin monotherapy with dose titrated up to 2,500 mg/day for 24 weeks during Treatment Period 1
* Patients will take dapagliflozin 10 mg in combination with metformin ≤ 1,500 mg (daily dose) for further 24 weeks during Treatment Period 2 Following the randomisation procedure, patients will receive investigational products at each visit as scheduled by Treatment Period 1. After the Randomisation Visit (Visit 2), the patient should attend the study centre for Visits 3, 4, and 5 (Day 28, Day 86, and Day 168, respectively) for efficacy and safety assessments. At Visit 5 (Day 168), the patient will receive investigational products as required by Treatment Period 2. Further Visits 6, 7 and 8 will be scheduled on Day 196, Day 252, Day 336, respectively.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: